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Comparison of middle nasal meatus adhesion and middle turbinate position in patients with chronic sinusitis with polyposis, after functional endoscopic sinus surgery (FESS) in the modified splint and control groups

Protocol summary

Study aim
Comparison of middle meatus adhesion and middle turbinate position in patients with chronic sinusitis with polyposis after functional endoscopic sinus surgery in modified splint and control groups
Design
A randomized, parallel-group, unblinded, phase 2-3 clinical trial on 53 patients (106 nostrils). The rand function of Excel software will be used for randomization.
Settings and conduct
This study will be conducted at Besat Hospital, Hamadan. The left and right sides of the nose will be randomly assigned to the group with or without the modified splint. In the modified splint group, a 2 mm thick Silastic splint from Richard will be used. All patients will be discharged on the first day after surgery. Oral antibiotics for 2 weeks, budesonide nasal spray two puffs every 12 hours, cetirizine tablet one daily, and nasal irrigation with saline three times daily are recommended. The modified splint will be removed 7 days after surgery by the resident under local anesthesia for all patients.
Participants/Inclusion and exclusion criteria
Participants are patients with chronic sinusitis with polyposis. Inclusion criteria are age over 18 years, chronic sinusitis with bilateral nasal polyps, and failure to respond to drug therapy. Exclusion criteria: previous history of endoscopic sinus surgery, allergic fungal sinusitis, known primary immunodeficiency, patients who need to undergo septoplasty, and need for additional packing with mesh.
Intervention groups
One side of the nose will have a modified splint inserted into the middle meatus after the end of FESS. The control group is the other side of the nose will not have a modified splint inserted into the middle meatus.
Main outcome variables
The primary outcome of the study is the turbidity of the middle meatus, Discharge, the amount of nasal crusting, and the recurrence of the disease after endoscopic sinus surgery are other outcomes of the study.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151123025202N47
Registration date: 2025-08-08, 1404/05/17
Registration timing: prospective

Last update: 2025-08-08, 1404/05/17
Update count: 0
Registration date
2025-08-08, 1404/05/17
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-09-06, 1404/06/15
Expected recruitment end date
2026-06-20, 1405/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of middle nasal meatus adhesion and middle turbinate position in patients with chronic sinusitis with polyposis, after functional endoscopic sinus surgery (FESS) in the modified splint and control groups
Public title
Adhesion of the middle nasal meatus and position of the middle turbinate in patients with chronic sinusitis with polyposis, after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic sinusitis with bilateral nasal polyps Failure to respond to drug treatment Age 18 years and above Patient consent to participate in the study
Exclusion criteria:
Previous history of endoscopic sinus surgery Allergic fungal sinusitis Known cases of primary immunodeficiency Patients requiring septoplasty Need more packing with mesh
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 53
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a card number is prepared and 53 letters are written on IR and 53 letters are written on IL, each of which is placed in an envelope with an aluminum cover, the lid is taped and placed in a box. When the patients arrive, one of the envelopes will be randomly selected and opened by the ward nurse. If the selected letters are IR, the right nostril will be corrected by the splint and the left will be the control group. If the selected letters are IL, the left nostril will be corrected by the splint and the right will be the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
Sahahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2025-05-24, 1404/03/03
Ethics committee reference number
IR.UMSHA.REC.1404.120

Health conditions studied

1

Description of health condition studied
Chronic sinusitis with polyposis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis

Primary outcomes

1

Description
Adhesions of the middle nasal meatus
Timepoint
7 days, 1 month, and 3 months after surgery
Method of measurement
Nasal endoscopy and viewing endoscopic images

2

Description
Nasal discharge and crusting
Timepoint
7 days, 1 month, and 3 months after surgery
Method of measurement
Ask the patient about an intranasal examination

3

Description
Recurrence of sinusitis
Timepoint
One month and 3 months after surgery
Method of measurement
Clinical examination, patient questioning, sinus endoscopy

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A modified splint is used on the intervention side. A phenylephrine-impregnated patch is placed in the nose to establish hemostasis, and then it is removed during recovery. In these patients, a 2 mm thick Richard brand silastic splint is used. After the surgery is completed, the distance from the columella edge to the axilla is measured using a surgical ruler, and then the splint is cut half to one centimeter longer than the measurement from the distal end. The upper edge of the splint is resected to locate the maximum thickness of the splint in the middle meatus (spacer). After the splint is cut and trimmed, it is inserted under the vision of the endoscope in such a way that the distal part of the middle meatus space is completely subaxillary. Then the splint is sutured and fixed at two points using 3-0 nylon cut sutures, and then it is evaluated again by the endoscope to ensure correct placement. Then a phenylephrine-impregnated patch is inserted to establish hemostasis. It is removed during recovery.
Category
Treatment - Devices

2

Description
Control group: In the control group or contralateral nose, the modified splint is not used.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Javaneh Jahanshahi
Street address
Shahid Beheshti Blvd
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Shahid Fahmide
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Javaneh Jahanshahi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shahid Beheshti Blv
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
009881338274184
Email
Besat@Umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared except for authors names
When the data will become available and for how long
From 2026 onwards it is permissible
To whom data/document is available
Clinical professionals and Researchers in all fields
Under which criteria data/document could be used
For treatment of patients and develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
What processes are involved for a request to access data/document
Send and receive email
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